SYSTEM DI-60 MAIN UNIT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SYSMEX CANADA INC. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    20618
  • 사례 위험등급
    III
  • 사례 시작날짜
    2017-07-31
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Sysmex america inc. has been made aware of a software defect on versions 5.0.1 and 6.0.1 running on the sysmex di-60 that may cause the operator to misidentify a slide flagged with a barcode error. if the sysmex di-60 processes a slide with an unreadable barcode the barcode reader will take a picture of the barcode. the software will assign the slide a temporary id beginning with err in the format of erryyyymmddhhmmss (yyyy=year mm=month dd=day hh=hour mm=minute ss=second). the image of the barcode will be stored in the database and displayed in the order data screen within the software so the customer can later identify the slide and reassign it with the correct sample id for the slide. if a subsequent slide is manually loaded on the sysmex di-60 and has a barcode with a err prefix the slide will be linked with the image of the barcode from the prior slide the sysmex di-60 found unreadable. this can give the false impression the sysmex di-60 barcode reader could not read the barcode of the subsequent slide with a barcode with the err prefix. if the user is not careful there is a risk the user will assign the slide with the err prefix printed on it with an incorrect order id via the image captured from a different slide. the sp-10 will automatically auto-assign the sample id when unable to read the barcode on the tube in the format of err050000000001 and auto-increment. these slides are not automatically routed to the sysmex di-60.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: CC286297 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: BC188562 (Lot serial: >10 NUMBERS CONTACT MFG)
  • 제품 설명
    SYSTEM DI-60 MAIN UNIT;SYSTEM DI-60 REMOTE REVIEW SOFTWARE
  • Manufacturer

Manufacturer

  • 제조사 주소
    MISSISSAUGA
  • 제조사 모회사 (2017)
  • Source
    HC